Evidence map›Paper›PMID 37416689›Full record

ArticleHeliyon2023

Establishing a novel and sensitive assay for bioactivity determination of anti-CD25 antibodies.

Maoqin Duan, Chuanfei Yu, Yalan Yang, Zhihao Fu, Chunyu Liu, Jialiang Du, Meng Li, Sha Guo, XiaoJuan Yu, Gangling Xu and 2 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Heliyon, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 69% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 1 institution in 1 country.

Maoqin DuanKey Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech, Division of Monoclonal Antibody Products, National Institutes for Food and Drug Control, Beijing 102629, China.
Chuanfei YuKey Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech, Division of Monoclonal Antibody Products, National Institutes for Food and Drug Control, Beijing 102629, China.
Yalan YangKey Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech, Division of Monoclonal Antibody Products, National Institutes for Food and Drug Control, Beijing 102629, China.
Zhihao FuKey Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech, Division of Monoclonal Antibody Products, National Institutes for Food and Drug Control, Beijing 102629, China.
Chunyu LiuKey Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech, Division of Monoclonal Antibody Products, National Institutes for Food and Drug Control, Beijing 102629, China.
Jialiang DuKey Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech, Division of Monoclonal Antibody Products, National Institutes for Food and Drug Control, Beijing 102629, China.
Meng LiKey Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech, Division of Monoclonal Antibody Products, National Institutes for Food and Drug Control, Beijing 102629, China.
Sha GuoKey Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech, Division of Monoclonal Antibody Products, National Institutes for Food and Drug Control, Beijing 102629, China.
XiaoJuan YuKey Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech, Division of Monoclonal Antibody Products, National Institutes for Food and Drug Control, Beijing 102629, China.
Gangling XuKey Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech, Division of Monoclonal Antibody Products, National Institutes for Food and Drug Control, Beijing 102629, China.
Yuting MeiKey Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech, Division of Monoclonal Antibody Products, National Institutes for Food and Drug Control, Beijing 102629, China.
Lan WangKey Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech, Division of Monoclonal Antibody Products, National Institutes for Food and Drug Control, Beijing 102629, China.
National Institutes for Food and Drug Control · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Anti-CD25 antibodies have been approved for renal transplantation and has been used prior to and during transplantation by the Food and Drug Administration (FDA). However, no reported bioassays have been reflected the mechanism of action (MOA) of anti-CD25 antibodies. Here, we describe the development and validation of a reporter gene assay (RGA) based on the engineered C8166-STAT5RE-Luc cells expressing endogenous IL-2 receptors and a STAT5-inducible element-driven firefly luciferase in C8166 cell lines. The RGA was fully validated according to the International Conference on the Harmonization of Technical Requirements for the Registration of Pharmaceuticals for the Human Use-Q2 (ICH-Q2). After optimization, the assay showed excellent specificity, linearity, accuracy, precision, and robustness. Due to the MOA relatedness and the excellent assay performance, the RGA is suitable for exploring the critical quality attributes (CQAs), release inspection, comparability and stability of anti-CD25 mAbs.

Indexed as

Anti-CD25 antibodyBioassayIL-2Reporter gene assay

Identifiers

PMID37416689
PMCPMC10320283
OpenAlexW4381988645

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.